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临床试验/NCT04505865
NCT04505865招募中不适用

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
Change in arterial inflammation by PET imaging

研究概览

简要总结

This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.

详细描述

This randomized controlled imaging study will be performed to evaluate the impact of mindfulness-based stress reduction via a mind body program on arterial inflammation in individuals with self-identified high levels of stress and stable coronary artery disease. Individuals will undergo baseline FDG-PET and magnetic resonance imaging (MRI) and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks (1:1) with stratification by age and sex. The stress reduction sessions focus on developing an understanding of stress physiology and the physiology of the relaxation response, on developing a regular practice of eliciting the relaxation response, and on learning cognitive behavioral and positive psychology/resilience skills.

During the screening period, patient acceptability for the study will be assessed based on medical history, concomitant medications, physical examination, and clinical laboratory test results. Acceptability for study participation will be confirmed for subjects who identify as having increased levels of stress and/or a Perceived Stress Scale (PSS) score >=14. Once the patient has passed screening, they will undergo baseline imaging followed by randomization and group assignment. Approximately 12 weeks after randomization, all individuals will return for follow-up imaging and evaluation.

FDG PET/MRI scans will be performed during the study for baseline and follow up to assess the intervention's impact on the brain as well as systemic and arterial inflammation along with other changes in related biomarker and imaging parameters. The Perceived Stress Scale will be delivered prior imaging during both imaging visits to measure perceived psychological stress. During both imaging sessions, subjects will be exposed to overt faces to measure signals during brain imaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must admit to feeling stressed and/or have PSS score > 13 (moderate stress)
  • Must be willing to complete stress reduction course and imaging sessions with < 3 missed appointments in last year
  • Known clinical cardiovascular disease with prior atherosclerotic myocardial infarction, percutaneous intervention or bypass surgery > 6 months before entry, or severe coronary calcifications on computed tomography or coronary calcium score >400
  • Stable symptoms without symptomatic heart failure or arrhythmia or planned revascularization
  • Maximally tolerated and stable medical regimen for 90 days that does not include a high intensity statin for clinical reasons
  • No neurological disease or systemic inflammatory disease/current anti-inflammatory therapy
  • No active psychiatric disease/medications or substance abuse (including tobacco smoking or more than moderate alcohol) for last 6 months
  • No current participation in cardiac rehab or prior participation in stress reduction
  • For imaging: no pregnancy, weight > 300 lbs., metal implants, uncontrolled hyperglycemia, or inability to provide consent or comply

排除标准

  • 未提供

结局指标

主要结局

Change in arterial inflammation by PET imaging

时间窗: 12 weeks

Change in arterial inflammation measured as the ratio of tracer activity in the walls of the aorta and carotid arteries to the activity of background venous blood on FDG PET imaging (ratio without units) - from initial imaging to repeat imaging

次要结局

  • Change in brain activity by PET(12 weeks)
  • Change in bone marrow activity by PET(12 weeks)
  • Change in inflammatory biomarkers(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael T. Osborne

Instructor of Medicine

Massachusetts General Hospital

研究点 (2)

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